MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01556685
First received: October 20, 2011
Last updated: September 12, 2013
Last verified: March 2012

October 20, 2011
September 12, 2013
March 2011
October 2011   (final data collection date for primary outcome measure)
  • Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Percentage of patients with interferon induced Nabs measured in luciferase test [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01556685 on ClinicalTrials.gov Archive Site
  • Rate and duration of corticosteroid use for relapse [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Need and duration of hospitalization for relapse [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Genetic profile of patients with relation to their predisposition to Nab development [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • The interferon activity will be tested by neopterin protein activation (level before IFNbeta1a IM injection and 48 hours after the injection) [ Time Frame: twice measured: - Day 1 before IFN injection - 48-72hours after the IFN injection ] [ Designated as safety issue: No ]
  • Genetic profile of population with relation to predisposition to Nab generation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Rate/ duration of corticosteroid use for relapse [ Time Frame: measured up to 3 years prior to enrollment @ Day 1 ] [ Designated as safety issue: No ]
  • Need/ duration of hospitalization for relapse [ Time Frame: measured up to 3 years prior to enrollment @ Day 1 ] [ Designated as safety issue: No ]
  • Genetic profile of patients with relation to the predisposition to Nab development [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Interferon activity will be tested by neopterin protein activation before and after injection [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia

This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine the frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the long term retrospective observational evaluation conducted to measure efficacy, adherence to therapy, tolerability, and safety in subjects with relapsing MS related to antibody status and treatment.

The primary objective of this study is to evaluate the frequency of neutralizing antibodies in patients treated with IFN beta 1a IM (Avonex) and IFN beta 1a IM biosimilar formulation (Jumtab).

Secondary objectives:

  • Evaluate the effect of Nabs on the severity of the relapses on each treatment group, measured by:

    • The need and duration of steroid courses
    • The need and duration for hospitalization.
  • To evaluate the safety and tolerability of the IFN beta 1a IM treatments [Avonex and Jumtab].
  • To identify the genetic profile of the patients with relation to the predisposition to Nab development (HLA DR4 (in particular HLADRB1* 0401 and 0408) and DR16 (in particular HLADRB1* 1601)
  • At selected sites: To evaluate the influence of the interferon and the Nabs on the activation of neopterin
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Multiple Sclerosis
  • Other: clinical and neurological evaluation
    The day of the usual IFN beta 1a IM injection
  • Other: Blood Sample
    For evaluation of interferon-related Nab
  • Genetic: Blood Sample
    genetic evaluation - predisposition to Nab generation
  • Active Comparator: Group 1 Avonex
    Approximately 90 subjects treated with IFN beta 1a IM 30μg
    Interventions:
    • Other: clinical and neurological evaluation
    • Other: Blood Sample
    • Genetic: Blood Sample
  • Active Comparator: Group 2 Jumtab
    Approximately 90 subjects treated with IFN beta 1a IM biosimilar
    Interventions:
    • Other: clinical and neurological evaluation
    • Other: Blood Sample
    • Genetic: Blood Sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
Not Provided
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection:

    • No limitation of age, EDSS or other disease parameters will be applied.
    • Subject with MS
    • Subjects treated with IFN beta 1a IM (Avonex) or the biosimilar formulation of IFN beta 1a IM (Jumtab) in line with the local prescription information
    • The IFN beta 1a IM (Avonex or Jumtab) treatment should be the first disease modifying treatment
    • The subject should be treated with the same drug for at least 18 months and up to a maximum of 3 years

Exclusion Criteria:

  • Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection:

    • No informed consent
    • Patients with combination therapy (IFN + immunosuppressive therapy)
    • Patients pretreated with immunosuppressive therapy
    • Treatment with any investigational product, including investigational symptomatic therapies for MS (e.g., 4Aminopyridine) and investigational therapies for NonMS indications, during the review period.

NOTE: subjects may receive investigational symptomatic therapies for MS at any time prior to evaluation period.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   Mexico
 
NCT01556685
AVX-MEX-09-17
No
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP